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Vertex Ventures HC · 2 days ago
Senior Manager, QA Sterility Assurance & Contamination Control
Waltham, MA
Full-time
Onsite
Senior Level
7+ years exp
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Responsibilities
Lead management of the site contamination control strategy and program.
Facilitate microbiological/sterility assurance risk assessments.
Participate in root cause investigation for OOS and deviations for Sterility Assurance, Aseptic Processing, and Microbiological non-conformance events.
Author, review, and approve Quality records (deviations, CAPAs, change controls) and documentation (policies, standard operating procedures, work instructions).
Quality partner for aseptic process simulation design and execution for Cell and Gene Therapy programs.
Cross-functional on-the-floor coaching/training on aseptic operations, cleaning and microbial testing.
Interact with clients and regulatory agencies as an aseptic subject matter expert.
Qualification
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Required
BA/BS degree with 7+ years of experience in pharmaceutical, biotechnology, or biologics operation.
5+ years of work experience in Microbiology Testing, Contamination Control, Aseptic Operations, and/or Sterility Assurance
Working knowledge of microbiological and sterility testing, aseptic process simulations, environmental monitoring, clean room management, cGMP regulations is required.
Strong communication and project management skills.
Ability to work well in a face paced environment.
Company
Vertex Ventures HC
Vertex Ventures HC invests in various sectors of the healthcare industry, including biopharmaceuticals, medical devices and digital health. It is a sub-organization of Vertex Ventures.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Lori Hu
Managing Director
Recent News
2023-11-17
2023-11-07
2023-09-12
Company data provided by crunchbase
